Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone
|ClinicalTrials.gov Identifier: NCT02046252|
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: Oral naltrexone Drug: Naltrexone implant||Phase 2|
This is a double blind, double-dummy, placebo controlled, randomized trial of a 48-week course of implant naltrexone vs. oral naltrexone, each arm with drug counseling every two weeks, for 200 HIV+ patients who are in early remission from opioid dependence, and who are interested in relapse prevention treatment medication, and starting their first episode of antiretroviral therapy at the Botkin Infectious Disease Hospital in St. Petersburg or the Leningrad Regional AIDS Center. Early remission was chosen because relapse risk is the highest at this point, thus maximizing the chances for detecting a naltrexone effect. The first antiretroviral therapy treatment episode was chosen because it is feasible (relatively few opioid addicted Russians have been treated with antiretroviral therapy), and because the virus is less likely to have developed secondary resistance.
Participants will be recruited from the AIDS and addiction programs and who meet study admission criteria will be stratified within each site according to baseline viral load (>100,000 copies/<100,000 copies) and cluster of differentiation 4 (CD4) count (>50/<50 copies). Participants will be randomized to a treatment condition, receive a naloxone challenge, and if pass be prescribed oral naltrexone or oral placebo and implant/implant placebo), and given a schedule for addiction counseling and HIV treatment appointments. A 2-week supply of oral medication will be provided at each bi-weekly counseling session, and will be re-implanted at weeks 12, 24, and 36. Only the research pharmacist will know the group assignments, however the blind can be broken in case of emergency.
The primary outcome measure will be to compare implanted naltrexone versus oral naltrexone on ability to achieve a viral load of <400 copies at weeks 24 and 48.
Secondary outcomes are to compare the efficacy of the two addiction treatments; to study the adherence to antiretroviral therapy; to evaluate time to relapse and the number of days to relapsed; to evaluate decline in CD4 counts; to evaluate HIV risk behavior; to evaluate opioid positive urine tests; and to evaluate the number of days that patients will keep their scheduled appointments. The Investigator will also monitor psychiatric symptoms, other drug use, and overall adjustment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adherence to HIV Therapy in Heroin Addicts: Oral vs. Extended Release Naltrexone|
|Actual Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Naltrexone Implant + ART
Naltrexone implant maintenance 48 weeks plus psychotherapy N=100
Drug: Naltrexone implant
Other Name: Prodetoxon implant
Active Comparator: ON Oral Naltrexone
ON (oral) naltrexone maintenance 48 weeks plus psychotherapy N=100
Drug: Oral naltrexone
Other Name: Revia
- Viral Load [ Time Frame: 1 year ]equal to or less than 400 copies
- Adherence to ART [ Time Frame: 1 year ]Medication Event Monitoring System (MEMS) cap measured at prescribed dosing per medication
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046252
|Botkin Infectious Disease Hospital|
|Leningrad, Russian Federation|
|Principal Investigator:||George E Woody, MD||University of Pennsylvania|